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The Acute Effect of Statins on Inflammatory Markers of Athersclerotic Tissue

Primary Purpose

Carotid Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
simvastatin
placebo
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing carotid endarterectomy
  • No previously known side effects of statins
  • Patients who will sign an informed consent
  • Age > 18 years old
  • No signs of current infection

Exclusion Criteria:

  • Patient hypersensitive to any component of this medication
  • Patients with acute liver disease (AST> normal value)
  • Patients with chronic liver disease (history of Hepatitis B or C)
  • Patients with renal failure (creatinine > 3.0)
  • Patients with unexplained muscle pains and aches
  • Patients with rheumatoid arthritis
  • Patients with Lupus
  • Current cancer treatment
  • Patients on cyclosporin, digoxin, Itraconazole, Ketoconazole and other antifungal azoles, the macrolide antibiotics and antidepressant nefazodone
  • Pregnant females

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    Two 80 mg pills simvastatin taken 24 hours prior to surgery

    Two 80 mg pills placebo are taken 24 hours prior to surgery

    Outcomes

    Primary Outcome Measures

    This study is being done to see if giving the study drug, Simvastatin, quickly lessens the swelling of plaque tissue (tissue around your heart) and plaque movement in patients undergoing cqrotid endarterectomy procedure.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 21, 2007
    Last Updated
    February 14, 2011
    Sponsor
    Mayo Clinic
    Collaborators
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00587717
    Brief Title
    The Acute Effect of Statins on Inflammatory Markers of Athersclerotic Tissue
    Official Title
    The Acute Effect of Inflammatory Markers of Atherosclerotic Plaque in Humans
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2002 (undefined)
    Primary Completion Date
    March 2006 (Actual)
    Study Completion Date
    March 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Mayo Clinic
    Collaborators
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study is being done to determine if the acute administration of the drug Simvastatin reduces plaque tissue inflammation and plaque instability in patients undergoing carotid endarectomy

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carotid Artery Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    35 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    Two 80 mg pills simvastatin taken 24 hours prior to surgery
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    Two 80 mg pills placebo are taken 24 hours prior to surgery
    Intervention Type
    Drug
    Intervention Name(s)
    simvastatin
    Other Intervention Name(s)
    Zocor
    Intervention Description
    Two 80 mg pills simvastatin taken 24 hours prior to surgery
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    take 2 80 mg pills placebo 24 hours prior to surgery
    Primary Outcome Measure Information:
    Title
    This study is being done to see if giving the study drug, Simvastatin, quickly lessens the swelling of plaque tissue (tissue around your heart) and plaque movement in patients undergoing cqrotid endarterectomy procedure.
    Time Frame
    24 prior to surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients undergoing carotid endarterectomy No previously known side effects of statins Patients who will sign an informed consent Age > 18 years old No signs of current infection Exclusion Criteria: Patient hypersensitive to any component of this medication Patients with acute liver disease (AST> normal value) Patients with chronic liver disease (history of Hepatitis B or C) Patients with renal failure (creatinine > 3.0) Patients with unexplained muscle pains and aches Patients with rheumatoid arthritis Patients with Lupus Current cancer treatment Patients on cyclosporin, digoxin, Itraconazole, Ketoconazole and other antifungal azoles, the macrolide antibiotics and antidepressant nefazodone Pregnant females
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amir Lerman, MD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://clinicaltrials.mayo.edu
    Description
    Mayo Clinic Clinical Trials

    Learn more about this trial

    The Acute Effect of Statins on Inflammatory Markers of Athersclerotic Tissue

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